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Pharma: Outsourcing


Five reasons to outsource API procurement


There’s a reason why DIY renovation disasters make for good television. Watching a hapless homeowner backslide from cost-conscious bravado (“I’ll be my own general contractor!”) into a quagmire of sunk costs and crumbling drywall feels gratifying, somehow. There’s a delicious high-minded pride in knowing that we wouldn’t make the same mistakes. If it came to it, we would have the good sense to call an expert and get the job done right the first time. What does this have to do with API procurement and supply chain management? Everything.


P


harmaceutical development and manufacturing is an expensive business. Owners and managers, particularly those in young, lean firms with paper-thin margins, are under tremendous pressure to lower operational costs. Under these conditions, many choose to


manage their supply chain themselves (“I’ll be my own API specialist!”). Sometimes, with a great expenditure of effort and time, it works. But when it doesn’t, the whole house can collapse. Your supplier fails to deliver on time. Your materials spend weeks at the border, ensnared in regulatory red tape. Or they arrive, only to fail your quality control testing. Repairing this damage takes money and time you don’t have, and attention you can’t afford to spare. There will always be companies that choose to accept these risks and pursue the DIY approach. That’s fine — let them at it. But for those of you who got into this business for the science, not the paperwork, there’s an alternative way forward: partnering with API procurement and supply chain specialists. They work in the midst of complex and evolving global regulations to ensure door-to-door delivery of your materials while you remain focused on innovation and growth.


Five reasons to outsource API procurement


Here are five reasons to outsource API procurement and supply chain management to a trusted and experienced specialist:


1 You’ll get VIP access to API manufacturers Because the best procurement specialists enjoy a pristine reputation in the industry, high-profile API manufacturers lift the velvet rope to give them access to services that simply aren’t available to most lone companies. Phone calls are answered. Meetings are prompt and successful. Requests for special arrangements, like small or large quantities or materials with different specifications, are swiftly and creatively accommodated. By partnering with a procurement


specialist, even a small biotech startup can negotiate with the influence of a much larger and more mature pharmaceutical company, leading to better pricing, tighter timelines, and more flexibility.


2 You’ll be introduced to the perfect supplier (who you didn’t know existed) Access to the big players in the API supply chain is one thing. But many companies need services of a different sort, the kind that only niche API manufacturers with a modest customer list can provide. These suppliers, less well-known but no less qualified, have the agility and bandwidth to partner with biotech firms looking to control their costs (through API lifecycle management, for example) or develop unique formulations (requiring modifications to approved ingredients). In a crowded market, these innovative suppliers can be hard to find. Once found, they can be hard to distinguish from less reliable lookalikes. A procurement specialist can help. They’ve done that vetting already, including only suppliers with spotless reputations and modern, compliant CGMP operations. The most diligent of these specialists will personally approve manufacturing facilities in their annual inspections. This means you get connected with suppliers nimble enough to meet your project’s needs, yet small enough that you’re treated not as one customer among many, but as a priority partner with important objectives.


3 Your supply chain will deliver at hyperspeed Due diligence. These two simple words conceal the immense regulatory complexity of the pharmaceutical supply chain: tariff classifications, FDA notifications, licensing, certifications of suitability, end- use letters — the list goes on. An experienced procurement specialist knows how to manoeuvre your APIs through this deluge and into


your lab smoothly and quickly, streamlining your entire supply chain. Simply place your order and a specialist


will help move your sensitive materials from the manufacturing site through customs clearance to your facility, securely and according to product specifications.


4 You’ll be compliant. Always There’s a trick to ensuring that your operations and materials comply with regulators’ expectations, even in today’s world of intense scrutiny


18 March/April 2021 • Issue 2 Photo © iStock / 3D_generator


www.chemicalsknowledgehub.com


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